K252971
- 510(k) number
- K252971
- Device name
- Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- Applicant
- C.R. Bard, Inc. GA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-03-17
- Date received
- 2025-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252971.pdf
Official FDA record: K252971
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.